- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04978155
Usefulness of Doppler Ultrasound Carried Out by the Vascular Surgeon After Loco-regional Anesthesia for Preferred Access
Preoperative vascular mapping with echo-Doppler is acknowledged as indispensable to create an arteriovenous fistula for haemodialysis (AVF). The conditions for performing this examination are not always ideal (venous vasospasm in cool temperatures, variability of the volume status in the dialysis patient).
On the other hand, the use of a loco-regional anaesthesia (LRA) results in the vasodilation of the limb thus rendering it possible to use the veins which were initially considered too small.
The aim of this study is to assess the functionality of our AVF when ultrasound identification was used by the surgeon after the LRA. These results have been compared with those of the preceding year during which this identification was not implemented.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators conducted a prospective study in the year 2020 during which all the patients (n=90) had an AVF creation with preoperative venous identification by the surgeon at university hospital of TOULOUSE (France)(echo group).
All the patients gave their consent, and the database was anonymised upon completion.
All patients were seen in a preoperative consultation with venous mapping carried out by a physician specialised in the use of Doppler ultrasonography. Following this consultation, a type of fistula was programmed in accordance with the Silva criteria (notably a vein with a diameter of over 2.5mm and an artery of 2mm). On the day of the operation, loco-regional anaesthesia was performed under sonographic guidance according to the previous description . The decision of the block approach and the choice of local aesthetic agent was left to the discretion of the anaesthesiologist.
The surgeon carried out an ultrasound and modification of the type of AVF was then made if the Silva criteria differed from those described during initial consultation. The modification could be a more distal creation, a more proximal creation, a change of vein or a change of artery.
The investigators succeeded to create more distal AVF when the vein had a diameter of over 2.5mm after LRA. Furthermore, the investigators reassembled the AVF when the vein appeared too small or residual (for example, following the attachment of an infusion having occurred between mapping and the surgery).
The same team of 4 surgeons participated in the creation of the AVF for both the echo group and the control group.
All patients were given a preoperative assessment of their heart function and cardiovascular risk factors (HTA, diabetes, smoking, dyslipidaemia). Prior strokes and coronary diseases were also registered as well as the patients' BMI and American society of anesthesiology score.
The definition of the good development of the haemodialysis access is based on the National Kidney Foundation's criteria: Blood flow>600ml, diameter over 6mm and lower depth of 6mm. On the other hand, permeability was based on the criteria of the Society for Vascular Surgery : primary permeability lasts from the creation to the first dilation episode or transposition of anastomosis required to maintain the access. Assisted primary permeability ends at the time of the first occlusion episode. Secondary permeability ends with the abandonment or the definitive withdrawal of the AVF due to failure.
The first postoperative consultation took place at around the 6th week after the creation which is the normal time necessary for the smooth development of an AVF .
The investigators compared all these results with our control group which consists of all the patients who had a native AVF placed during the year 2019 without having received immediate preoperative ultrasound and therefore there was no alteration in the surgical project in relation to that planned at the time of the consultation. Demographic data was similarly compiled and all the evaluation criteria compared
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Toulouse, France, 31059
- aurelien Hostalrich
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Native AVF access
- During the year 2020
- Preoperative mapping during the consultation
- Loco-regional anesthesia
Exclusion Criteria:
- Redo surgery
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Echo group
All the patients (n=90) who had an AVF creation with preoperative venous identification by the surgeon at CHU de TOULOUSE (echo group).
|
Just after locoregional anesthesia, the surgeon perform a duplex ultrasound to determinate if the target vessel chosen to create the arterio-venous fistulae match with the pre-operative duplex performed during the consultation.
So the plan can be changed such as more distal, more proximal creation, changing vein or artery target.
|
Control
All the patients (n=93) who had a native AVF placed during the year 2019 without having received immediate preoperative ultrasound and therefore there was no alteration in the surgical project in relation to that planned at the time of the consultation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functionality of the AVF at the time of the postoperative
Time Frame: 6 weeks
|
An AVF is defined as functional if all the criteria of the good development of the haemodialysis access (based on the National Kidney Foundation's criteria) are present : Blood flow>600ml, diameter over 6mm and lower depth of 6mm
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The rate of planning change between the surgical project at the time of the consultation and the AVF that is finally placed
Time Frame: During the surgery
|
During the surgery
|
|
Primary, assisted primary and secondary permeability of our accesses
Time Frame: 12 months
|
permeability was based on the criteria of the Society for Vascular Surgery : primary permeability lasts from the creation to the first dilation episode or transposition of anastomosis required to maintain the access.
Assisted primary permeability ends at the time of the first occlusion episode.
Secondary permeability ends with the abandonment or the definitive withdrawal of the AVF due to failure
|
12 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Congenital Abnormalities
- Pathological Conditions, Anatomical
- Cardiovascular Abnormalities
- Vascular Malformations
- Arteriovenous Malformations
- Vascular Fistula
- Fistula
- Arteriovenous Fistula
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics
Other Study ID Numbers
- ECHO FAV
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arterio-venous Fistula
-
Beni-Suef UniversityCompletedPost Dialysis Arterio-Venous Fistula Puncture SitesEgypt
-
Poissy-Saint Germain HospitalUnknownArterio-venous Fistula, Puncture, Chronic DeseaseFrance
-
Cliniques universitaires Saint-Luc- Université...CompletedChronic Hemodialysis Patients | Vascular Abord: Native Arterio-venous Fistula | Buttonhole CannulationBelgium
-
University of South FloridaUnknownChronic Kidney Diseases | Arterio-Venous Fistula | Steal SyndromeUnited States
-
Assiut UniversityNot yet recruitingArterio-venous Fistula
-
University Hospital of LimerickCompleted
-
Kaneka CorporationClinSearchUnknownArteriovenous Malformations | Aneurysm | Arterio-venous FistulaGermany, Belgium
-
Kafrelsheikh UniversityRecruitingArterio-venous FistulaEgypt
-
Far Eastern Memorial HospitalRecruiting
Clinical Trials on Duplex ultrasound performed by the surgeon after locoregional anesthesia
-
Ryo ItabashiCompleted
-
University Hospital, Strasbourg, FranceUnknownContamination of the Handles | Quality of the LaryngoscopyFrance
-
Naestved HospitalCompletedDyspnea | Pleural Effusion | Ultrasound | Diaphragm Movement | Patient Reported OutcomesDenmark
-
Central Hospital, Nancy, FranceRecruiting
-
Centre Hospitalier Universitaire de Saint EtienneDirection Générale de l'Offre de SoinsNot yet recruitingSedation and Analgesia MonitoringFrance
-
Zagazig UniversityRecruiting
-
Groupe Hospitalier de la Region de Mulhouse et...Completed
-
Ataturk UniversityCompletedAnesthesia, Local | Cesarean Section Complications | HypotensionTurkey
-
Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje...Charles University, Czech RepublicCompleted